DAVID GRANOVSKY

Posts Tagged ‘irb’

TEXAS OKs EXPERIMENTAL STEM CELL THERAPY LIMITS – questions

In STEM CELLS IN THE NEWS on April 14, 2012 at 5:08 am

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Texas OKs experimental stem cell therapy limits

Friday, April 14, 2012

Will this move by Texas lead to a faster process of FDA approval and insurance coverage? – Boonie

 

My gut says: baby steps. They need to define the IRB process and make sure all the pieces of the machine work well. There are many factors which will unfold now.

Will other states fall after Texas like for medical marijuana?

Will Texas stand alone and all US stem cell companies open clinics there?

Will patients go to a clinic in Texas regulated by an IRB with zero experience over a treatment center outside the US with thousands of successes?

Can the FDA approval process be changed from clinical trial to produce drugs INTO a process oriented hybrid?

Will insurance cover it…ie will the American people, many whom think all stem cells are embryonic still so all stem cells = murder, many whom don’t know about the thousands of trials and tens of thousands patients treated, want to ‘foot the bill’ for these Texas treatments?

Many many questions.

Rome. Built. Not one day.

Baby steps…but a step in the right direction.

 

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TEXAS OKs EXPERIMENTAL STEM CELL THERAPY LIMITS – explained

In STEM CELLS IN THE NEWS on April 14, 2012 at 3:44 am

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Texas OKs experimental stem cell therapy limits

Friday, April 14, 2012

What this means:

1. This is not blind distribution of medicine with no control. The legislature demands full transparency & disclosure (not available to patients in clinical trials). In trials, patients have no idea what they are getting if anything! There is no patient, only guinea pigs.

2. There is oversight control by an Institutional Review Board. There will not be rampant, unchecked treatments or “growth motivated by cash only.”

Standard FDA clinical trials regulate only how DRUGS are brought to market. Adult stem cell therapies are not drugs, they are a procedure, a process, a protocol & must be treated differently in the courts & in practice like PRPs (which are legal. 2x standard?). It was way past time to end the idea: ‘the result of all medical intervention is a prescription drug.’ “Give a small boy a hammer, & he will find that everything he encounters needs pounding,” Texas is unburdened from the yoke of those blinded by a faith in a system that demands the mandatory adherence to “one size fits all,” “one size fits drugs,” “drugs fit all.”

Adult stem cells have a proven record of safety & efficacy in studies & trials around the world – thousands of them. American medical professionals are so Ameri-centric, they throw away or ignore anything conducted outside the USA…when our health system is ranked 37th in the world. This arrogance is suspect. “We’re 7th in literacy, 27th in math, 22nd in science, 49th in life expectancy,178 in infant mortality…” and the US throws away other country’s clinical trials & studies?  Perhaps we should throw away our entire medical system & start from scratch or at least start taking pointers from some other countries on how to improve our health care/medical system…countries who apparently do a better job at it than we do like ranked 27th to 36th: United  Arab  Emirates, Israel, Morocco, Canada, Finland, Australia, Chile, Denmark, Dominica and Costa Rica.

With our CLINICAL TRIAL system, a human patient is used as a Guinea pig & sacrificed for the patient of tomorrow, blindly & randomly given medications or not, given placebos or not or given nothing.  They are Guinea pigs by definition. There is no patient, there is no empowerment, there are no rights, there is no agenda for healing. The health of one patient is sacrificed today for the health of patients of tomorrow whom apparently have more value. Categorization of any human patient as dispensable, even in order to generate data for a drug treatment to be sold to a different patient tomorrow, is reprehensible.  Clinical trials = no agenda for healing today.

With ADULT STEM CELL TREATMENTS, a human is given a therapy today intended to heal that person today. That person. Their health, their survival, that patient is of paramount importance. Their life has value, today. Adult stem cell treatments are simply, a treatment today, paid for today, for a human today to heal today, live today and into tomorrow.

I guess you can be a Guinea Pig for future patients tomorrow or you can be an empowered patient for yourself today.  All this legislature does, is give you the choice. In the end, our choices are all we ever have.

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TEXAS OKs EXPERIMENTAL STEM CELL THERAPY LIMITS!!!

In STEM CELLS IN THE NEWS on April 13, 2012 at 1:11 pm

PERRY DID IT!!

I DON’T THINK I BELIEVE IT!!

IS IT POSSIBLE??

IS IT??

https://i2.wp.com/static3.itsuxtobefat.com/uploads/omg.jpg

Texas OKs experimental stem cell therapy limits

National / World News 1:46 p.m. Friday, April 13, 2012

The rules require patients to give their consent and a review board must approve the procedure before using adult stem cells.

Supporters say establishing formal rules will lead to more medical innovation. Critics warned that the rules don’t provide enough protection for patients and could lead to an explosion of doctors promoting unproven, expensive treatments.

Perry had his own stem cells injected into his back.

The Food and Drug Administration hasn’t approved using adult stem cells to help people heal from surgery, but experimentation is common. Some scientists tout the possible benefits, including treatment for heart disease, diabetes and some cancers.

Texas OKs experimental stem cell therapy limits  | ajc.com.

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TEXAS – PERRY – STEM CELLS – NEW RULING

In STEM CELLS IN THE NEWS on April 13, 2012 at 4:10 am

Today (Friday) there is a very significant legislation ruling in Texas (prompted by Gov Perry and his use of stem cells during spinal fusion surgery) which if passed will allow the use of stem cell therapy in Texas under a few conditions. How will this effect the patients and the stem cell industry?


Back story:
MEDICAL BOARD Gives Early OK to Adult Stem Cell Rules – Part 1 April 9, 2012
https://repairstemcell.wordpress.com/2012/04/08/medical-board-gives-early-ok-to-adult-stem-cell-rules/
MEDICAL BOARD’s proposed stem-cell policy under fire – Part 2 April 9, 2012
https://repairstemcell.wordpress.com/2012/04/08/medical-boards-proposed-stem-cell-policy-under-fire-part-2/
DRIVING THE FDA DUNE BUGGY INTO THE STEM CELL OCEAN https://repairstemcell.wordpress.com/2012/04/04/driving-the-fda-dune-buggy-into-the-stem-cell-ocean/

This is by no means a political message and I neither endorse nor denounce Gov Perry but I do appreciate the incredible attention he has been able to focus on the benefits of adult stem cell therapies and if this legislature goes through, thousands of patients with no hope can be help with them.

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